Smiths Medical HOTLINE Fluid Warming Set L-80 recallZ-1444-2014 · Smiths Medical ASD, Inc. · initiated Mar 17, 2014

Class II Terminated All recalls posted in April 2014

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged

FDA root cause category: Nonconforming Material/Component

What the company is doing

Smiths Medical issued Urgent Field Safety Notice Recall on 3/17/14 via mail service. Distributors will be instructed to notify their customers. The Field Safety Notice will also include an Urgent Recall Notice Confirmation Form (Confirmation Form) that consignees will be instructed to send back to Smiths Medical for carrying out the action and tracking effectiveness.Accounts are to inspect inventory and return recalled product. If you should have any questions regarding this information, please contact Shirley Duggan, Quality System Engineer at 1-781-763-9335 or by E-Mail [email protected].

Recall details

Recall number: Z-1444-2014
Recall class: Class II
Status: Terminated
Initiated by the company: Mar 17, 2014
Posted by the FDA: Apr 9, 2014
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 870 units
Product code: LGZ
FDA submissions: K911383
Distribution: Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.

Product description

Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions

Code information (models, lots, serial numbers)

2513261 2531612 2540540 2545044 2588656

Other devices under the same FDA submission

10 devices cleared under K911383 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Level 1 HL-90
Icu Medical, Inc. · Warmer, thermal, infusion fluid
991 reports
Level 1 HL-390
Icu Medical, Inc. · Warmer, thermal, infusion fluid
634 reports
Level 1 L-70
Icu Medical, Inc. · Warmer, thermal, infusion fluid
1 recall385 reports
Level 1 L-70NI
Icu Medical, Inc. · Warmer, thermal, infusion fluid
114 reports
Level 1 L-10
Icu Medical, Inc. · Warmer, thermal, infusion fluid
41 reports
Level 1 L-370
Icu Medical, Inc. · Warmer, thermal, infusion fluid
24 reports
Level 1 HL-390-38
Icu Medical, Inc. · Warmer, thermal, infusion fluid
9 reports
Level 1 HL-90-38
Icu Medical, Inc. · Warmer, thermal, infusion fluid
5 reports
Level 1 HL-390-40
Icu Medical, Inc. · Warmer, thermal, infusion fluid
3 reports
Level 1 HL-90-40
Icu Medical, Inc. · Warmer, thermal, infusion fluid
2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 67714).

Z-1443-2014 · Terminated
Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditio…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

How recalls are matched to devices · Editorial policy · Report an error on this page